* Validation of validity, superiority, and safety of data analysis results using AT-Patch compared to 48-hour Holter test results * Number of subjects: 100 (including 10% dropout rate) * Performance and safety were verified by simultaneously attaching a 48-hour Holter and a wearable Holter device (ATP-C75 or ATP-C135).
Prospective, sequential, superiority test Patients diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter monitoring. * 48-hour Holter vs ATP-C75 (48-hour comparison/total time comparison) * 48-hour Holter vs ATP-C135 (48-hour comparison/total time comparison) * Comparison between IDs
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 14 days.
A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 7 days.
Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials
* 48-hour Holter vs ATP-C75 (48-hour comparison/7days) * 48-hour Holter vs ATP-C135 (48-hour comparison/14days)
Time frame: ATP-C75 : 7day , ATP-C135 : 14day
Arrhythmia detection rate by test time in the test group and control group after using the clinical trial medical device
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Time frame: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
Comparison of the concordance rate of the analysis results of the simultaneous attachment time in the test group and control group after using the clinical trial medical device
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Time frame: ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison)
User response evaluation (satisfaction) in the test group and control group after using the clinical trial medical device
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Time frame: ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days
Arrhythmia detection rate in the test group and control group by hypertrophic cardiomyopathy subtype (Apical HCM, Non-apical HCM)
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Time frame: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
Arrhythmia detection rate by test group (ATP-C75, ATP-C135)
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period
Time frame: ■ATP-C75 vs ATP-C135 ( 7days vs 14days )
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